Regulatory Affairs Manager

hace 1 día

Madrid, Madrid, España QualitecFarma A tiempo completo

Regulatory Affairs ManagerSupervise and coordinate the execution of formulation, manufacture, dossier construction, registration of products. Also supervise the registration of companies, where applicable. Coordinate junior staff as and when required.

Full TimeMadrid, Spain

Experience required:At least 3 years in a similar work position.

Duties required:

  • Assist on products registration (human medicines, medical devices, cosmetics, food supplements, etc), variations, renewals, or any other activity regarding the maintenance of the dossiers (e.g., readability tests). These procedures could be National or European procedures (Centralized, Decentralized and Mutual Recognition Procedures).
  • Ensure regulations compliance (on both European and local regulations).
  • eCTD compilation
  • Collect and evaluate scientific data.
  • Prepare labelling, PIL, SmPC and mockups of medicinal products, and adaptation to current QRDs.
  • Provide strategic advice throughout the development of new products.
  • Managing teams of colleagues involved with the development of new dossiers.
  • Keeping abreast of international legislation, guidelines, and customer practices in all countries that the company is working.
  • Advise clients and manufacturers on regulatory requirements.
  • Work with specialist computer software and resources (eCTDmanager, Lorenz Validator, RAEFAR, etc).
  • Negotiate with regulatory authorities for marketing authorisation, variations, or any other required activity for the approval of medicinal products in Spain and other countries, as needed.

Education and skills required:

  • B.Sc degree in life science (Chemistry, Biology, Pharmacy, etc).
  • Master or related course in Regulatory Affairs will be desirable.
  • English level: High (spoken and written).

Job Type: Full-time

Pay: 35,000.00€ - 55,000.00€ per year

Work Location: In person

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